FX Shoulder Prospective Clinical Study
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- FX Shoulder Solutions
- Study ID
- NCT06078865
- Status
- Recruiting
Conditions
- Fracture, Shoulder
- Osteoarthritis Shoulder
- Rotator Cuff Syndrome of Shoulder and Allied Disorders
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- FX Artificial Shoulder Prosthesis — DEVICEHumelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System
Study Details
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Key Dates
- Start date
- Mar 31, 2021
- Status verified
- Feb 2026
- Primary completion
- Dec 30, 2031
- Completion
- Dec 30, 2031
Study Design
- Enrollment
- 600 participants (estimated)
Arms
- Arm: SubjectsSubjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
Primary Outcome Measure
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS): [ Time Frame: 2 years ]
Central Contacts
- Brian Wasonga, MHA800-280-0775
- Brian Rogers, BS800 280-0775
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| OrthoArizona | Gilbert | Arizona | 85297 | William Paterson, MD (PRINCIPAL_INVESTIGATOR) |
| First Settlement Orthopedics | Marietta | Ohio | 45750 | John Henry, MD (PRINCIPAL_INVESTIGATOR) |
| Orthopedics Rhode Island | Wakefield | Rhode Island | 02879 | Michael Bradley, MD (PRINCIPAL_INVESTIGATOR) |
| Texas Orthopedic Specialists | Bedford | Texas | 76021 | Howard Harris, MD (PRINCIPAL_INVESTIGATOR) |
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